Intravaginal device with fluid transport plates and methods of making

ABSTRACT

Apparatus for producing an intravaginal device includes a forming tool having an aperture, a male tool having a plurality of forming blades arranged radially about an aperture, at least one bonding element, and at least one moveable pushrod. The forming tool includes a holding plate having a plurality of vacuum ports, and the aperture of the forming tool is located in the forming plate. The aperture of the forming tool has a plurality of slots connected to and extending therefrom. The bonding element is moveable toward the aperture in the forming tool. The apertures are aligned along a machine axis to permit the pushrod to move a fluid storage element through each aperture, the forming blades of the male tool are aligned with the slots of the forming tool, and guide edges of the forming blades accommodate a fluid storage element aligned with the aperture of the male tool.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 11/661,535filed Mar. 26, 2009, which is the national stage filing under 371 ofinternational application PCT/US2005/017113, filed May 13, 2005, whichclaims the benefit of U.S. provisional application 60/572,055, filed onMay 14, 2004, and is a continuation-in-part of U.S. application Ser. No.10/848,257, filed on May 14, 2004, and is a continuation-in-part of U.S.application Ser. No. 10/847,951, filed on May 14, 2004, the completedisclosures of which are hereby incorporated herein by reference for allpurposes.

This invention is related to the following copending applications filedon even date herewith: “Intravaginal Device with Fluid AcquisitionPlates” (U.S. Ser. No. 60/574,054; Atty Docket No. PPC-5073),“Intravaginal Device with Fluid Acquisition Plates” (U.S. Ser. No.10/847,952; Atty Docket No. PPC-5070), “Fluid Management Device withFluid Transport Element for use within a Body” (U.S. Ser. No.10/847,951; Atty Docket No. PPC-5071 G-2a), “Method of UsingIntravaginal Device with Fluid Transport Plates” (U.S. Ser. No.10/848,347; Atty Docket No. PPC-5076), “Tampon with Flexible Panels”(U.S. Ser. No. 10/848,257; Atty Docket No. PPC-5074), and “Method ofUsing an Intravaginal Device with Fluid Transport Plates” (U.S. Ser. No.10/848,208; Atty Docket No. PPC-5075), the content of each of which isincorporated herein.

FIELD OF THE INVENTION

The present invention relates to devices for capturing and storing bodyfluid intravaginally. More particularly, the present invention relatesto a method of capturing body fluid intravaginally via a fluid transportelement and transporting the body fluid to a fluid storage element wherethe fluid is stored. Additionally, this application relates to methodsof making such devices

BACKGROUND OF THE INVENTION

Devices for capturing and storing bodily fluid intravaginally arecommercially available and known in the literature. Intravaginal tamponsare the most common example of such devices. Commercially availabletampons are generally compressed cylindrical masses of absorbent fibersthat may be over-wrapped with an absorbent or nonabsorbent cover layer.

The tampon is inserted into the human vagina and retained there for atime for the purpose of capturing and storing intravaginal bodilyfluids, most commonly menstrual fluid. As intravaginal bodily fluidcontacts the tampon, it should be absorbed and retained by the absorbentmaterial of the tampon. After a time, the tampon and its retained fluidis removed and disposed, and if necessary, another tampon is inserted.

A drawback often encountered with commercially available tampons is thetendency toward premature failure, which may be defined as bodily fluidleakage from the vagina while the tampon is in place, and before thetampon is completely saturated with the bodily fluid. The patent arttypically describes a problem believed to occur that an unexpanded,compressed tampon is unable to immediately absorb fluid. Therefore, itpresumes that premature leakage may occur when bodily fluid contacts aportion of the compressed tampon, and the fluid is not readily absorbed.The bodily fluid may bypass the tampon.

To overcome this problem of premature leakage, extra elements have beenincorporated into a basic tampon to try to direct and control the flowof fluid toward the absorbent core.

For example, U.S. Pat. No. 4,212,301 (Johnson) discloses a unitaryconstructed digital tampon having a lower portion compressed preferablyin the radial direction to form a rigid, rod-like element, whichprovides a central rigidified elongated core and an upper portion leftsubstantially uncompressed. After insertion, the uncompressed portionmay be manipulated to contact the vaginal wall to provide an immediateseal against side leakage. The uncompressed portion allows for highabsorbent capacity immediately upon insertion. While this tampon mayallow for a certain amount of protection from bypass leakage, theuncompressed portion may become saturated before the compressed portionhas a chance to expand and become absorbent.

U.S. Pat. No. 6,358,235 (Osborn et al.) discloses a “hollow” bag-liketampon that may have an interior projection made from highly compressedabsorbent material. The interior projection is preferably attached tothe inside surface of the head of the tampon. The hollow tampon portionmay include at least one pleat in the absorbent outer surface and issoft and conformable. The tampon is not pre-compressed to the pointwhere the fibers temporarily “set” and re-expand upon the absorption offluid. The absorbent portions of the tampon can saturate locally, whichleads to bypass leakage.

U.S. Pat. No. 6,177,608 (Weinstrauch) discloses a tampon having nonwovenbarrier strips that are outwardly spreadable from the tampon surface toreliably close the free spaces believed to exist within a vaginalcavity. The nonwoven barrier strips extend about the tampon in acircumferential direction at the surface or in a helical configurationabout the tampon and purportedly conduct menstrual fluid toward thetampon surface. The nonwoven barrier strips are attached to the cover bymeans of gluing, heat bonding, needle punching, embossing or the likeand form pleats. The nonwoven barrier strips are attached to the tamponblank and the blank is embossed, forming grooves extending in alongitudinal direction. While this tampon purports to direct fluid tothe core, it attempts to achieve this by forming pockets of absorbentnonwoven fabric. In order to function, it appears that these pocketswould have to be opened during use to allow fluid to enter. However,based upon current understandings of vaginal pressures, it is notunderstood how the described structure could form such an opened volume.

U.S. Pat. No. 6,206,867 (Osborn) suggests that a desirable tampon has atleast a portion of which is dry expanding to cover a significant portionof the vaginal interior immediately upon deployment. To address thisdesire, it discloses a tampon having a compressed central absorbent corehaving at least one flexible panel attached along a portion of the sidesurface of the core. The flexible panel appears to provide the“dry-expanding” function, and it extends outwardly from the core awayfrom the point of attachment. The flexible panel contacts the innersurfaces of the vagina when the tampon is in place and purportedlydirects fluid toward the absorbent core. The flexible panel is typicallyattached to the pledget prior to compression of the pledget to form theabsorbent core and remains in an uncompressed state.

U.S. Pat. No. 5,817,077 (Foley et al.) discloses a method of preservingnatural moisture of vaginal epithelial tissue while a using a tamponwhere the tampon has an initial capillary suction pressure at the outersurface of less than about 40 mm Hg. This allows the tampon to absorbvaginal secretions without substantially drying the vaginal epithelialtissue. The multiple cover layers can be used to increase the thicknessof the cover material. While this represents a significant advancementin the art, this invention does not address by-pass leakage.

Additionally, U.S. Pat. No. 5,545,155 (Hseih et al.) discloses anexternal absorbent article that has a set of plates separated by spacerelements. The plates may be treated to affect wettability so that fluidwill flow easily across the surface. Extending through the upper plateis a plurality of openings, which allow fluid to flow with littlerestriction into the space between the upper and lower plates. When thefluid flows downward in the z-direction from the upper plate to thelower plate, it will then flow laterally in the x- and y-directions.Therefore, this external absorbent article can contain fluid gushes, butit does not appear to address the problems relating in particular tointravaginal devices, such as a tampon.

While the prior art is replete with examples of sanitary protectionarticles that capture bodily fluids both externally and intravaginally,these examples do not overcome the problem of premature failure oftenidentified as by-pass leakage that commonly occurs while using internalsanitary protection devices. Many solutions to this problem haveinvolved increasing the rate of expansion of a highly compressedabsorbent article.

SUMMARY OF THE INVENTION

We have found a novel way to address the problem of premature productfailure. This invention is not dependent on the expansion of thecompressed absorbent but rather incorporating an element, which isadaptable to the vagina. In our invention, we increase the contact areaof the absorbent device and thereby reduce by-pass leakage.

In one aspect of the invention, an intravaginal device has a fluidstorage element and at least one fluid transport element in fluidcommunication with the fluid storage element. The fluid storage elementhas a longitudinal axis, an insertion end, and a withdrawal end. The atleast one fluid transport element has a first plate a second platecoupled to the first plate. The first plate has an outwardly orientedsurface and an inwardly oriented surface. The second plate has a firstsurface disposed and maintained in facing relationship with the inwardlyoriented surface of the first plate and an opposite surface. The secondplate is capable of separating from the first plate sufficiently toprovide inter-plate capillary action. The at least one fluid transportelement is bendable about an axis substantially parallel to thelongitudinal axis of the fluid storage element. The fluid transportelement may substantially envelop the fluid storage element, and it maybe attached to the withdrawal end of the fluid storage element, on atleast one longitudinal side of the fluid storage element, to itselfproximate the withdrawal end of the fluid storage element, and/or to thewithdrawal string.

In another aspect of the invention, a method of producing anintravaginal device includes attaching an individual sheet to a fluidstorage element to form at least one fluid transport element capable ofextending radially away from the fluid storage element, folding the atleast one fluid transport element about an axis parallel to thelongitudinal axis of the fluid storage element, and packaging theresultant intravaginal device. The material from which the individualsheet is produced has properties useful to move bodily fluids.

In still another aspect of the invention, an alternate method ofproducing an intravaginal device includes separating an individual sheetfrom a supply of material, engaging the individual sheet with theinsertion end of a fluid storage element and with pleating edges offorming blades, urging the individual sheet through a forming tool,bonding at least a portion of the individual sheet to the fluid storageelement, folding the at least one fluid transport element about an axisparallel to the longitudinal axis of the fluid storage element, andpackaging the resultant intravaginal device. The material from which theindividual sheet is produced has properties useful to move bodilyfluids. Relative movement of the forming tool in relation to the fluidstorage element and the pleating edges of forming blades urges theindividual sheet through the forming tool. Bonding the at least oneportion of the individual sheet forms at least a portion of theindividual sheet into at least one fluid transport element that iscapable of extending radially away from the fluid storage element.

In still another aspect of the invention, apparatus for producing anintravaginal device includes a forming tool, a male tool, at least onebonding tool, and at least one pushrod. The forming tool includes aholding plate having a plurality of vacuum ports formed in a facethereof. A substantially circular aperture is disposed on the plate anda plurality of slots connects to and extends from the aperture. The maletool has a plurality of forming blades. Each forming blade having aguide edge, and the blades are arranged radially about an aperture inthe male tool. The at least one bonding element is moveable toward theaperture in the forming tool to engage and bond an individual sheet to afluid storage element held within the male tool. The pushrod is moveablethrough apertures of the forming tool and male tool, and these aperturesare aligned along a machine axis to permit the pushrod to move fluidstorage element through the apparatus.

Other aspects and features of the present invention will become apparentto those ordinarily skilled in the art upon review of the followingdescription of specific embodiments of the invention in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 a shows a side elevation of an intravaginal device having a fluidtransport element in fluid communication with a fluid storage element.

FIG. 1 b shows a cross-sectional view of the device in FIG. 1 a takenalong line b-b.

FIG. 1 c shows the transverse cross-section shown in 1 b, after theintroduction of a fluid between the plates of the fluid acquisitionelement.

FIG. 2 shows an enlarged cross-section of an embodiment of a fluidtransport element of the present invention having nubbles to separate aset of film plates.

FIGS. 3 a-c show enlarged cross-sections of alternate embodiments offluid transport elements of the present invention formed of polymericapertured formed film having differing orientations of the formed filmplates.

FIGS. 4 a-e show various aspects and orientations of an intravaginaldevice of the present invention.

-   -   FIG. 4 a shows a perspective view of a tampon having a plurality        of fluid transport elements extending therefrom that are formed        from a folded sheet material.    -   FIG. 4 b shows a side elevation of the tampon with a plurality        of fluid transport elements wrapped around the fluid storage        element.    -   FIG. 4 c shows a transverse cross-section along line 4 c-4 c in        FIG. 4 b.    -   FIG. 4 d shows a side elevation of the tampon of FIG. 4 a.    -   FIG. 4 e shows a top elevation of the tampon of FIG. 4 a.

FIG. 5 shows a transverse cross-section of an alternate embodimenthaving a pair of fluid transport elements partially extending into thestorage element.

FIG. 6 a shows a side elevation of an alternate embodiment of thepresent invention in which a cover material is bonded to itself in theform of a bag to form a fluid transport element in fluid communicationwith a fluid storage element.

FIG. 6 b shows a cross-sectional view of the device in FIG. 6 a takenalong line 6 b-6 b.

FIG. 7 shows a side elevation of an embodiment of the present inventionin which the fluid transport element envelops the fluid storage elementand is bonded at the withdrawal end to the withdrawal string.

FIG. 8 shows a side elevation of an embodiment of the present inventionin which the fluid transport element envelops the fluid storage elementand is bonded to the base of the fluid storage element.

FIG. 9 shows a side elevation of an embodiment of the present inventionin which the fluid transport element is attached to the insertion end ofthe fluid storage element.

FIG. 10 shows a side elevation of an embodiment of the present inventionin which the fluid transport element is bonded to the base of the fluidstorage element.

FIG. 11 shows a bottom plan view of the embodiment shown in FIG. 10.

FIG. 12 shows a side elevation of an embodiment of the present inventionin which the fluid transport element is bonded to the longitudinal sideof the fluid storage element in a series of aligned discrete bonds.

FIG. 13 shows a side elevation of an embodiment of the present inventionin which the fluid transport element is bonded in at least oneattachment zone having discrete spots of bonds on the longitudinal sideof the fluid storage element.

FIG. 14 shows an enlarged view of a section of the embodiment shown inFIG. 13.

FIG. 15 shows a schematic perspective view of apparatus according to thepresent invention useful to manufacture an intravaginal device.

FIG. 16 shows the schematic perspective view of apparatus of FIG. 15including a fluid storage element and a sheet of material prior toformation of the fluid transport element.

FIG. 17 shows a schematic perspective view of a male tool useful in theapparatus of FIG. 15.

FIG. 18 shows a transverse cross-section of a human vagina with anintravaginal device according to FIG. 4 b disposed therein with onefluid transport element extending away from the fluid storage element.

FIG. 19 shows a transverse cross-section of a human vagina with anintravaginal device according to FIG. 4 b disposed therein with thefluid transport elements remaining wrapped around the fluid storageelement.

FIG. 20 shows the device of FIG. 4 contained in an applicator devicepackaging element.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein in the Specification and the Claims, the term “bodilyfluid” and variants thereof mean bodily exudates, especially liquidsthat are produced by, secreted by, emanate from, and/or discharged froma human body.

As used herein in the Specification and the Claims, the term “fluids”and variants thereof relate to liquids, and especially bodily fluids.

As used herein in the Specification and the Claims, the term “sheet” andvariants thereof relates to a portion of something that is thin incomparison to its length and breadth.

As used herein in the Specification and the Claims, the term “parallelplate” and variants thereof relates to a system of at least tworelatively parallel sheets that are capable of moving fluids throughinter-plate capillary action. The individual “plates” in the system maybe flexible and/or resilient in order to move within their environment.However, they may be maintained in a substantially facing relationshipwith relatively constant separation at least in a localized portion oftheir structure (as compared with their relative length and width).Thus, two sheets could be fluted, but if the flutes were “nested”, thesheets would generally remain generally parallel in any given localizedportion.

As used herein in the Specification and the Claims, the term“inter-plate capillary action” and variants thereof mean the movement offluid due to a pressure difference across a liquid-air meniscus createdwithin a gap between two substantially parallel plates. The two platesneed not be held apart a specific distance, although they should beseparable to allow fluid to move between them by inter-plate capillaryaction. A general equation providing the rise of a fluid betweenparallel plates is reported as:

$h = \frac{2\sigma*\cos \; \theta}{\rho*g*d}$

in which:

h is rise of fluid between plates

σ is the surface tension of fluid in contact w/plate

θ is contact angle

ρ is density

d is distance between plates, and

g is the gravitational constant

Therefore, as long as the contact angle, θ, is less than 90°, there willbe some capillary attraction.

As used herein in the Specification and the Claims, the term “porousmedium” and variants thereof relates to a connected 3-dimensional solidmatrix with a highly ramified network of pores and pore throats in whichfluids may flow.

As used herein in the Specification and the Claims, the term “separableplates” and variants thereof mean any condition of separation of thefirst plate and the second plate, which allows fluid to move between theplates. This includes situations in which facing surfaces of adjacentfirst and second plates are touching one another in portions of oracross substantially all of their facing surfaces. This also includessituations in which the facing surfaces of the adjacent first and secondplates are separably joined together such that upon contact with fluid,the surfaces separate enough to provide for fluid to move between them.This further includes situations in which facing surfaces of adjacentfirst and second plates are joined together, as long as fluid may stillmove freely between the surfaces.

As used herein in the Specification and the Claims, the term “in fluidcommunication” and variants thereof relate to elements that are arrangedand configured to allow fluid to move therebetween.

As used herein in the Specification and the Claims, the term “coupled”and variants thereof relate to the relationship between two portions ofan integral structure that are either portions of the same material(e.g., two portions of a folded sheet) or are materials that are joinedtogether (e.g., two separate sheets that are bonded together).

As used herein in the Specification and the Claims, the term “fluidpervious” and variants thereof relate to a material that permits fluidor moisture to pass through without additional processing, such asaperturing. Therefore, for example, an untreated woven or nonwovenmaterial is fluid pervious and a continuous, plastic film or metal foilis not. A nonwoven permits fluid flow via the interstices betweenfibers, such that fluid can flow through, either by capillary actionand/or via a pressure differential from one side of the nonwoven to theother such as the pressure experienced by a tampon in use.

Referring to FIG. 1 a-1 c, this invention provides an intravaginaldevice 10 having at least one fluid transport element 12 in fluidcommunication with a fluid storage element 14 (FIGS. 1 a-1 c show twofluid transport elements 12 located on opposite sides of the fluidstorage element 14). The device may also include a withdrawal mechanism,such as a string 16.

The fluid storage element can be any convenient shape includingcylindrical, cup like, hourglass, spherical, etc. It can be an absorbentor a fluid collection device. It can be in separate sections with thefluid transport element(s) bridging or connecting the sections. Thefluid storage element can be made of any structure known in the art,such as compressed fibrous webs, rolled goods, foam, and the like. Thematerial may be formed as a unitary mass or a plurality of discreteparticles or agglomerations. The material may be compressed to maintaina relatively stable form, or it may be left relatively uncompressed. Forexample, the absorbent material may include a central portion ofabsorbent wood pulp material. The pulp may be covered by a thinabsorbent woven or nonwoven fabric and may be coterminous with the fluffpad or completely envelop it on all sides. Absorbent materials which areuncompressed or of low density have a much higher holding capacity forfluids than high density materials. A consideration for usinguncompressed materials is the bulk or volume that may be required inorder to achieve sufficient absorbency.

In one preferred embodiment, the fluid storage element 14 is anabsorbent tampon. Absorbent tampons are usually substantiallycylindrical masses of compressed absorbent material having a centralaxis and a radius that defines the outer circumferential surface of thetampon. Such tampons are disclosed in e.g., Haas, U.S. Pat. No.1,926,900; Dostal, U.S. Pat. No. 3,811,445; Wolff, U.S. Pat. No.3,422,496; Friese et al., U.S. Pat. No. 6,310,296; Leutwyler et al.,U.S. Pat. No. 5,911,712, Truman, U.S. Pat. No. 3,983,875; Agyapong etal., U.S. Pat. No. 6,554,814. Tampons also usually include afluid-permeable cover (which may include or be replaced by anothersurface treatment) and a withdrawal string or other removal mechanism.

Absorbent materials useful in the formation of the absorbent bodyinclude fiber, foam, superabsorbent, hydrogels, and the like. Preferredabsorbent material for the present invention includes foam and fiber.Absorbent foams may include hydrophilic foams, foams that are readilywetted by aqueous fluids as well as foams in which the cell walls thatform the foam themselves absorb fluid.

Fibers may be selected from cellulosic fiber, including natural fibers(such as cotton, wood pulp, jute, and the like) and synthetic fibers(such as regenerated cellulose, cellulose nitrate, cellulose acetate,rayon, polyester, polyvinyl alcohol, polyolefin, polyamine, polyamide,polyacrylonitrile, and the like).

The fluid storage element may also be in the form of a collection cup.Examples of such devices are disclosed in Zoller, U.S. Pat. No.3,845,766 and Contente et al., U.S. Pat. No. 5,295,984. Collectiondevices are designed to assume a normally open, concave configuration,with an open side facing a user's cervix. The collection devices may befolded, or otherwise manipulated, to facilitate insertion into thevaginal canal

The fluid transport element has at least a first plate 18 and a secondplate 20. The first and second plates combine to provide a set ofparallel plates, and the fluid transport elements 12 are shown asextending radially away from the fluid storage element 14. Additionalplates may also be incorporated into each fluid transport element 12.

The plates are configured and arranged to allow the introduction ofbodily fluid 22 to separate a plate from adjacent plate(s) (FIG. 1 c).At least one opening 24 allows the introduction of bodily fluids 22.Optionally, one or more spacer elements 26 can be inserted to establishand to maintain space between adjacent plates.

FIG. 1 b shows a pair of parallel plates prior to the introduction of afluid. In this view, the facing surfaces of the adjacent plates 18, 20are in contact. On the other hand, FIG. 1 c shows the set of parallelplates separated by a bodily fluid 22, providing an inter-platecapillary gap 28 between the inwardly oriented surface 30 of the firstplate 18 and the first surface 32 of the second plate 20. Thisinter-plate capillary gap 28 is sufficient to provide inter-platecapillary action to allow the fluid transport element 12 to acquire, tospread, and to move bodily fluids 22 from the vagina to the fluidstorage element 14. The first plate 18 also has an outwardly orientedsurface 34, and the second plate 20 also has an opposite surface 36.

The plates 18, 20 can be made of almost any hydrophobic or hydrophilicmaterial, preferably sheet-like. The thickness of each plate is notcritical. However, it can preferably be selected from the range of fromabout 0.005 to about 0.050 inch. The materials of construction and thethickness of the plates should be designed so that they are sufficientlystiff and/or resistant to wet collapse when exposed to fluid.

In particular, materials useful for forming the fluid transport elementmay have properties such as thermobondability to provide means toincorporate it into the intravaginal device. A representative,non-limiting list of useful materials includes polyolefins, such aspolypropylene and polyethylene; polyolefin copolymers, such asethylenevinyl acetate (“EVA”), ethylene-propylene, ethyleneacrylates,and ethylene-acrylic acid and salts thereof; halogenated polymers;polyesters and polyester copolymers; polyamides and polyamidecopolymers; polyurethanes and polyurethane copolymers; polystyrenes andpolystyrene copolymers; and the like. The fluid transport element mayalso be micro-embossed or apertured. Examples of films having aperturesinclude for example, three-dimensional apertured films, as disclosed inThompson, U.S. Pat. No. 3,929,135, and Turi et al, U.S. Pat. No.5,567,376, as well as two-dimensional reticulated film, such as thatdescribed in Kelly, U.S. Pat. No. 4,381,326. FIGS. 2 a-2 c illustratethree combinations of the apertured film of Thompson.

It may be helpful to keep the exposed surface of the fluid transportelement as smooth as possible. It may also be helpful to provide it witha low coefficient of friction. These characteristics may provide atleast two benefits: (1) the force required to insert the intravaginaldevice is reduced, and (2) it reduces the damage otherwise caused byscraping of soft, tender vaginal tissue during insertion, wearing andremoval. Plates 18 and 20 may be made from the same material oralternately, plate 18 may be made from a different material than plate20.

The parallel plates can have any physical structure to provide aresistance to fluid flow vector in the direction parallel to theinwardly oriented surface 30 of the first plate 18 and the first surface32 of the second plate 20 that is less than the resistance to fluid flowvector in the direction perpendicular to the plates. Preferably, theplates are made from any smooth material with a non-fibrous surface.Suitable materials include, without limitation, foil, waxed sheets,film, apertured film, etc. Each plate does not need to be made of thesame material as its corresponding parallel plate. For instance, thefirst plate 18 could be an apertured film to allow fluid to enter andthe second plate 20 could be a solid film to move fluid to the storageelement (as shown in FIG. 2). Of course, the parallel plates should beable to transport fluid between the two layers.

The fluid transport element 12 should be strong enough to preventrupturing during handling, insertion, and removal and to withstandvaginal pressures during use.

It is preferable that the surfaces of the fluid transport element 12 aresufficiently wettable by the bodily fluids that the intravaginal device10 is intended to collect (this results largely from a correlation ofthe surface energy of the plate surface and the bodily fluid(s)). Thus,the bodily fluid will easily wet the plate, and capillarity between theplates will draw these bodily fluids from a source to a fluid storageelement that is in fluid communication with the fluid transport element.

Surface treatments can be used to modify the surface energy of theplates 18, 20. In a preferred embodiment a surfactant is applied toincrease the wettability of the outer or inner surfaces of the parallelplates. This will increase the rate at which the bodily fluids are drawninto and spread between a pair of plates. The surfactant can be applieduniformly to either the inner or outer surfaces or it could be appliedwith varying coating weights in different regions.

A useful measure to determine the wettability of a plate surface is itscontact angle with 1.0% saline. Preferably, the contact angle with 1.0%saline is less than about 90 degrees.

In order to accomplish this, the materials of plates can be chosen fromthose materials that are known in the art to have low energy surfaces.It is also possible and useful to coat materials that have high-energysurfaces with a surface additive, such as a non-ionic surfactant (e.g.,ethoxylates), a diol, or mixtures thereof, in order to increase theirwettability by bodily fluids. Such additives are well known in the art,and examples include those described in Yang et al., US App. No.2002-0123731-A1, and U.S. Pat. No. 6,570,055. Other means of increasingwettability can also be used, such as by corona discharge treatment of,for example, polyethylene or polypropylene, or by caustic etching of,for example, polyester.

The parallel plates forming the fluid transport element can be of anyflexibility as long as the material is able to transport fluid to thefluid storage element while the device is in use. It is also preferablethat the fluid transport element be sufficiently flexible to provide theuser with comfort while inserting, wearing, and removing the device.

The surfaces of the first and second plates facing each other can have avariety of surface textures, ranging from smooth to highly textured. Thetexturing element may be included as a spacer 26.

The value of spacers 26 or texture may be based on the material'sability to withstand wet collapse when simultaneously subjected tocompressive forces and fluid.

The spacer elements 26 can be separate elements applied to one or moreof the plates, or they can be integral portions of a plate that extendaway from one of the plate's major surfaces. A representative list ofsuch separate spacer elements includes, without limitation, foamedmaterials such as polystyrene foam; particles such as beads andcrystals; discontinuous material such as netting, thread, wax, adhesive,any discrete element that causes a separation between the plates and thelike.

Integral spacer elements can be thickened portions of the plate materialor deformations of the plate material. A representative list of such anintegral spacer element includes, without limitation, nubbles,embossments, corrugations, deformations, and the like. Included in thisdefinition are surface treatments that permanently bond a secondarymaterial to a surface of a first. One example of a deformation isprovided as the sidewalls 38 of a “three-dimensional” polymericapertured formed film material shown in FIGS. 3 a-3 c. First and secondplates 18, 20 made from apertured formed film with the sidewalls 38facing each other as the inward surface 30 of the first plate 18 and thefirst surface 32 of the second plate 20 can be used to increase thetexture of the plates. While not wishing to be held to this theory, itis believed that the texturing reduces the viscosity of the fluid beingtransported. The texture can also be in a gradient. For example, in oneembodiment, the texture of the plates has a gradient from smooth nearthe edge of the plates where the fluid enters the fluid transportelement to more textured where the fluid is absorbed.

Referring again to FIG. 2, the spacer elements may be formed as nubbles40 extending from the inward surface 30 of the first plate 18 andresting on the first surface 32 of the second plate 20.

In order to maintain stability against sliding of the plates withrespect to each other and changing of the space between them, it isacceptable, and may be preferable, to secure some local areas of contactbetween the spacer elements 26 and the adjacent plate or even betweenspacer elements 26 of two adjacent plates. The plates may be securedthrough means known to those of ordinary skill in the art. Arepresentative list of such securing means includes, without limitation,thermobonding, adhering, crimping, embossing, ultrasonic bonding orwelding, and the like. The adhesive may be applied between the spacerelements and the first and second plates. Preferably, the adhesive iswettable.

The at least one opening can be at the edge of the plates, e.g., edgesof adjacent plates are separated, or plates themselves may have at leastone opening. The openings need not be uniform. For example, one openingmay be located at the edge of the plates and a plurality of smalleropenings or apertures can be distributed throughout one or more plate.Preferably, each plate has a plurality of openings distributedthroughout. An example of openings distributed throughout is anapertured film. The distribution can be uniform or arranged to provideregions of higher open area and regions of lower open area.

A plurality of openings or apertures 42 may extend through at least oneof the first and second plates 18, 20. These apertures 42 may extendcompletely through the plate and may be present in both of the plates.The apertures 42 allow fluid that contacts the outward surface 34 of thefirst plate 18 or the opposite surface 36 of the second plate 20 to flowinto the inter-plate capillary gap 28 between the plates with as littlerestriction as possible. In the example of apertured film, it ispreferred that the total surface area of the plate occupied by theopenings is from about 5% to preferably about 50%. More preferably, itwill be from about 25% to about 45%. Having this much open area formedin a plate will allow fluid that is deposited on that plate to easilyflow into the inter-plate capillary gap 28.

It is preferable that any individual opening (e.g., edge opening 24 offluid transport element 12 or aperture 42) is large enough to easilypass any highly viscous material, including menstrual fluid. While thegeometry of the openings is not critical, the openings 24, 42 should besized sufficient to allow easy passage of non-absorbable material. Ifthe apertures 42 are not circular, then the measurement should be madeacross the narrowest part of the opening, which would be mostrestrictive to the flow of non-absorbable material.

In the example of unapertured film that has an opening 24 at the ends ofthe plates 18, 20, the size of the opening 24 is a result of the fluid'sability to separate the plates.

It is preferred that the apertures 42 are large enough to let viscousfluid pass through but not too large to create too rough of a surface asto compromise the wearer's comfort. A preferred aperture 42 is circularand is between 10 mils and 40 mils in diameter. Most preferably it isbetween 18 mils and 27 mils.

Open area may be determined by using image analysis to measure therelative percentages of apertured and unapertured, or land, areas.Essentially image analysis converts an optical image from a lightmicroscope into an electronic signal suitable for processing. Anelectronic beam scans the image, line-by-line. As each line is scanned,an output signal changes according to illumination. White areas producea relatively high voltage and black areas a relatively low voltage. Animage of the apertured formed film is produced and, in that image, theholes are white, while the solid areas of thermoplastic material are atvarious levels of gray. The more dense the solid area, the darker thegray area produced. Each line of the image that is measured is dividedinto sampling points or pixels. The following equipment can be used tocarry out the analysis described above: a Quantimet Q520 Image Analyzer(with v. 5.02B software and Grey Store Option), sold by LEICA/CambridgeInstruments Ltd., in conjunction with an Olympus SZH Microscope with atransmitted light base, a plan 1.0× objective, and a 2.50× eyepiece. Theimage can be produced with a DAGE MTI CCD72 video camera.

A representative piece of each material to be analyzed is placed on themicroscope stage and sharply imaged on the video screen at a microscopezoom setting of 10×. The open area is determined from field measurementsof representative areas. The Quantimet program output reports mean valueand standard deviation for each sample.

Referring for example, to FIGS. 4 and 5, the first and second plates 18,20 may be extensions of the same sheet-like material, e.g., formed by afold in a sheet of material (as shown in FIGS. 4 a-4 c), or they may beseparate elements (i.e., adjacent to each other but not necessarilyjoined). In a folded embodiment, the material is preferably folded toform a pleat with the first and second plates facing each other.

A preferred embodiment with pleats is shown in FIGS. 4 a-4 e, where thepleats 44 are folds in the cover material 46. The pleats 44 createplates that are bendable about an infinite number of bending axes(b_(1-i)-b_(1-i)) that are substantially parallel to the longitudinalaxis (X-X) of the product, which longitudinal axis extends through theinsertion end 48 and withdrawal end 50. These bending axes allow theplates to wrap around the product, either partially or completely. Onesuch bending axis (b₁-b₁) is shown in FIG. 4 a.

The fluid transport element 12 is in fluid communication with the fluidstorage element 14 and directs fluid from the vagina to the storageelement 14. Generally, fluid will be directed from each fluid transportelement 12 to a particular region of the fluid storage elementassociated with that fluid transport element. Thus, if the device hasonly one fluid transport element 12, the fluid will contact the fluidstorage element in one interface 52.

Therefore, additional fluid transport elements 12 directing fluid toadditional locations of the fluid storage element 14 will improve theefficient usage of the fluid storage element 14. For example, two fluidtransport elements 12 could be directed to opposite sides of the fluidstorage element 14, as shown in FIGS. 1 a-1 c. Each additional fluidstorage element 12 can direct fluid to additional interface locations 52of the fluid storage element 14. For example, four evenly spaced fluidtransport elements 12 allow fluid to be directed to each quarter of thefluid storage element 14 surface as shown in FIGS. 4 a-e. Five or moreelements would provide even more direct access. This can allow the fluidto contact the fluid storage element 14 uniformly and help to prevent orreduce local saturation of the fluid storage element 14.

While the above description provides for direct fluid communicationbetween a fluid transport element 12 and the fluid storage element 14,direct fluid contact is not necessary. There can be fluid communicationthrough an intermediate element, such as a porous medium (e.g., a foamor fibrous structure), a hollow tube, and the like.

Enlarging the area of the interface 52 between the fluid transportelement 12 and fluid storage element 14 can also help to maximize thefluid communication. For example, elongating the interface by increasingthe length of the fluid transport element 12 allows more fluid to flowinto the fluid storage element 14.

The fluid transport element 12 may extend in any orientation from thesurface of the fluid storage element 14. It is not necessary for thefluid transport element to be on the surface of the fluid storageelement.

The inter-plate capillary gap 28 formed by first plate 18 and secondplate 20 can terminate at the interface 52 or can extend into and/orthrough the fluid storage element 14. An example of the fluid transportelement 12 extending into the fluid storage element 14 is shown in FIG.5. The first and second plates can have additional layers on top of themas long as these additional layers allow fluid to enter the plates. Thefirst and second plates can end at the boundary of the transport elementor can extend into the fluid storage element 14.

The fluid transport element 12 may be formed to extend from the surfaceof the fluid storage element 14 as in FIGS. 1 a-1 c. It can be made inany convenient shape, including semicircular, triangular, square,hourglass etc. Additionally the two plates of the element do not have tobe completely coextensive, as long as they are at least partially in afacing relationship.

Parallel plates can be held in close proximity to the storage element ina variety of ways including directly or indirectly via an additionalelement to the storage element. A variety of methods can be used toattach the fluid transport element 12 including but not limited to heat,adhesive, ultrasonic, sewing, and mechanically engaging the fluidstorage element 14. An example of a heat-bonded attachment 54 is shownin FIG. 4 a.

The fluid transport element(s) 12 can be attached at the sides,insertion end 48, and/or withdrawal end 50 of the intravaginal device.Additionally, the fluid transport element(s) 12 may be attached tothemselves and not to the storage element as in a relatively loose bagcovering of the storage element. The fluid transport element(s) 12 couldalso be attached to the withdrawal string.

The fluid transport element may be attached directly to the fluidstorage element or may be attached to itself in one or more locations.Such attachment or adherence to itself or to the fluid storage elementmay be by any known means, including, for example, adhesive, ultrasonic,co-embossing, thermobonding, mechanical bonding (such as crimping), andthe like. In one embodiment, the fluid transport element is formed of amaterial that is capable of being thermobonded. Alternately, thematerial may formed of two different materials having different meltingpoints, at least one of which would also be capable of thermobonding.

In an embodiment shown in FIGS. 6 a and 6 b, the cover material 46substantially envelops the fluid storage element 14 (shown as a tampon),forming a bag or sack structure 56. This structure provides a pair offluid transport elements 12′ formed by portions of the cover material46. In this embodiment, the cover material 46 is draped over theinsertion end 48 of the tampon with the edges of the material broughttogether about the withdrawal end 50 and then bonded to itself 54′. Theresulting fluid transport element 12′ can then be folded around thetampon in the manner shown in FIG. 4 b.

Other embodiments similar to that shown in FIG. 6 are possible. Forexample, FIG. 7 shows the attachment 54″ of the fluid transport element12 to the withdrawal string 16, and FIG. 8 shows the attachment 54″′ atthe withdrawal end 50, especially to the base 58 of the fluid storageelement 14 (the base 58 being the generally circular surface from whichthe withdrawal string 16 may extend). In all of these embodiments, thecover material 46 and the associated fluid transport element 12substantially envelop the fluid storage element 14 but do notsignificantly affect the performance of the fluid storage element 14.For example, if the fluid storage element 14 had been compressed andexpands upon exposure to fluid, the expansion of the fluid storageelement 14 would not be affected or inhibited by the attachment orbonding of the fluid transport element 12 to the fluid storage element14.

In the embodiments described and shown in FIGS. 6-8, it is not necessaryfor the fluid storage element 14 to be a unitary element. For example,the fluid storage element 14 may have multiple distinct portions orsegments. The segments may be attached together or may be discrete.Examples of discrete segments may be relatively loose absorbent materialor compressed cellulosic tablets. However, these discrete segments couldbe at least partially contained to permit the fluid transport element 12to form parallel plates, as described above.

In an alternate embodiment of the invention shown in FIG. 9, the fluidtransport element 12 and the fluid storage element 14 have an attachment54 at the insertion end 48 of fluid storage element 14. Pleats 44 formedin the fluid transport element 12 may be folded around the tampon aspreviously shown in FIG. 4 b. Additionally, the lower portions 60 of thesheet material may also be attached to withdrawal end 50 of the fluidstorage element 14, as described above and below, to prevent inversionof the fluid transport element 12 upon withdrawal.

In embodiments where the fluid transport element 12 is bonded orgathered at the withdrawal end 50 of the fluid storage element 14, it ispreferable to minimize bunching of the fluid transport element 12material to limit interference during insertion and withdrawal of thedevice.

Although not required, the sheet material used to form the fluidtransport element 12 may initially be in a shape such that the sheet hasat least one corner. The sheet material is placed over the fluid storageelement 14 such that at least one portion of the sheet extends away fromthe fluid storage element 14. In one embodiment, the sheet has aplurality of corners, and each corner may be attached to the withdrawalend 50 of the fluid storage element 14. For example, if four sets ofparallel plates are desired, the sheet material may be a square.

If the fluid storage element 14 is a compressed tampon having embossedgrooves such as those disclosed in U.S. Pat. No. 5,165,152 thedisclosure of which is hereby incorporated by reference, the attachmentmay be on the outer most surface (non-embossed) or in the grooves.Attachment may take place before, during, and/or after fluid storageelement 14 compression.

The embodiment of FIGS. 10 and 11 is similar to that of FIG. 9. Inparticular, the corners of the fluid transport element 12 are attachedto the base 58 of the fluid storage element 14. As seen in FIG. 11, thecorners preferably do not overlap the center of the circular base 58.

When a compressed tampon having grooves 60 is used as the fluid storageelement 14, it is likely that the tampon performs optimally if permittedto expand without restriction by the fluid transport element. While somecompressed tampons expand due to dry expansion, others expand whenexposed to fluid. One example of such a compressed tampon having groovesis the o.b.® tampon available from McNEIL-PPC, Inc., Skillman, N.J.

In the embodiments shown in FIGS. 12-14, the fluid storage element 14 isa compressed tampon having an exterior surface 62 and grooves 60.Grooves 60 have an interior portion, which becomes part of the exteriorsurface 62 of the tampon upon absorption of fluids and the resultanttampon expansion. Because the fluid transport element 12 is attached tothe exterior surface 62 of the tampon at its withdrawal end 50, it doesnot extend into the tampon grooves 60. Thus, the fluid storage element14 may expand without any interference from the fluid transport element12. In other words, the fluid transport element 12 does notsignificantly limit the functionality of the fluid storage element 14.Pleats 44′ form in the fluid transport element 12 and may be similarlyfolded around the tampon as previously shown in FIG. 4 b.

As shown in FIG. 12, a tampon having straight grooves is attached to thefluid transport element 12 using a series of heat bonds 54 along one ormore single line(s) along the tampon. This provides easier alignment ofthe attachment 54 and the exterior surface 62 of the tampon as the bondline may be registered accurately to avoid coinciding with the grooves60. Thus, the fluid transport element 12 may be readily attached alongthe longitudinal side without interfering with the expansion of thetampon.

In a similar embodiment shown in FIGS. 13 and 14, the fluid transportelement 12 may be attached along the longitudinal side of a tamponhaving spirally oriented grooves. In this embodiment an attachment zone64 of fluid transport element 12 extends from one lobe 66 and acrossgroove 60 to adjacent lobe 66′. As previously described, materials suchas apertured films have a certain amount of elasticity and may bedesigned to permit the tampon expansion, especially the material locatedwithin the interior portion of the grooves 60.

If desired, the attachment zone 64 may be oriented in any directionrelative to the longitudinal axis X-X of the fluid storage element 14.As shown in FIGS. 13 and 14, the attachment zone 64 comprises a matrixor other grouping of discrete bonds, such as dots or spots. This allowsthe interface between the fluid transport element 12 and the fluidstorage element 14 to remain as open to fluid flow as possible.

As previously mentioned and shown, the fluid transport element 12 may beattached to the fluid storage element 14 be any number of methods andembodiments. For example and with reference to FIGS. 15-17, a tampon maybe manufactured as shown in Friese, U.S. Pat. No. 4,816,100, and eitherFriese et al., U.S. Pat. No. 6,310,269, or Leutwyler et al., U.S. Pat.No. 5,911,712. However, after the tampon is formed and prior topackaging, an additional process employing a forming tool 102, a maletool 104 having a plurality of blades 106, and thermobonding elements108 applies a fluid transport element 12 to the fluid storage element14. The tools are aligned in a manner that the blades 106 of the maletool 104 cooperate with corresponding slots 110 in the forming tool 102.In addition, each of the tools has a central aperture 112, 112′ throughwhich a fluid storage element 14 may pass during processing.

In somewhat more detail, an individual sheet 114 of material isseparated from a supply (not shown) and placed on the forming tool 102.A vacuum is drawn across the forming tool 102 via a plurality of vacuumports 116 on the face 118 of the forming tool 102 to hold the individualsheet 114 in place.

The blades 106 of the male tool 104 are shown arranged radially aboutthe central aperture 112 in the male tool 104 (as shown in FIG. 17). Theblades 106 cooperate to hold the fluid storage element 14 in line withthe central aperture 112. A pushrod (not shown) is arranged to penetratethe central aperture 112 of the male tool 104 and to bear on the base ofthe fluid storage element 14. In the preferred embodiment shown in FIGS.15-17, four blades 106 are arranged at equal angles about the centralaperture 112. Each blade 106 provides a guide edge 120 facing the fluidstorage element 14 (when present) and a pleating edge 122 disposedradially outwards from the guide edge 120. The pleating edge 122 may bean edge that is adjacent the guide edge 120, or it may be separated byone or ore intermediate portions of the blade 106.

In operation, the male tool 104 holding a fluid storage element 14 ismoved along the machine axis (M-M) aligned with the central apertures112, 112′ toward the forming tool 102 carrying the individual sheet 114.The insertion end 48 of the fluid storage element 14 contacts theindividual sheet 114 and urges it through the central aperture 112′ ofthe forming tool 102. The pleating edges 112 of the blades 106 urgecorresponding portions of the individual sheet 114 through the slots 110of the forming tool 102 creating four sets of parallel plates 18, 20.

Once the fluid storage element 14 is inserted into the central aperture112′ of the forming tool 102 with only a portion of the withdrawal end50 remaining exposed, thermobonding elements 108 extend into the spacebetween the blades 106 to bond the four corners of the individual sheet110 to the exterior surface 62 of the fluid storage element 14, formingthe fluid transport element 12. The pushrod may then continue to movethe insertable device 10 into and through the central aperture 112′ ofthe forming tool 102. The fluid transport element 12 may then be foldedabout the fluid storage element 14. The resulting insertable device maythen be packaged in a hygienic overwrap as is well known in the art.

While the process described above in reference to FIGS. 15-17 employsblades 106 that have a guide edge 120 that is shorter than the fluidstorage element 14, this relationship may be altered. For example, theblades 106 could be modified to have a guide edge 120 that is longerthan the fluid storage element 14 or the system could otherwise bemodified to allow the leading portions 124 to contact the individualsheet 114, first. This permits the formation of a small gap between theinsertion end 48 of the tampon and the individual sheet 114 that mayallow more free expansion of the tampon without restriction by the fluidtransport element 14 during use.

During use, fluid transport element(s) 12 can take on manyconfigurations within the vagina. For example, a fluid transport element12 may extend into the vagina away from the fluid storage element 14, asshown in FIG. 18. Alternatively, and the fluid transport element(s) 12may remain wound about the fluid storage element 14, contacting thevaginal wall “W” only through the first surface 30 (FIG. 19).

A withdrawal mechanism, such as withdrawal string 16, is preferablyjoined to the intravaginal device 10 for removal after use. Thewithdrawal mechanism is preferably joined to at least the fluid storageelement 14 and extends beyond at least its withdrawal end 50. Any of thewithdrawal strings currently known in the art may be used as a suitablewithdrawal mechanism, including without limitation, braided (or twisted)cord, yarn, etc. In addition, the withdrawal mechanism can take on otherforms such as a ribbon, loop, tab, or the like (including combinationsof currently used mechanisms and these other forms). For example,several ribbons may be twisted or braided to provide parallel platesstructures.

Tampons are generally categorized in two classes: applicator tampons anddigital tampons, and a certain amount of dimensional stability is usefulfor each type of tampon. Applicator tampons use a relatively rigiddevice to contain and protect the tampon prior to use. To insert thetampon into a body cavity, the applicator containing the tampon ispartially inserted into the body cavity, and the tampon can be expelledfrom the applicator into the body cavity. In contrast, digital tamponsdo not have an applicator to help guide them into the body cavity andrequire sufficient column strength to allow insertion without using anapplicator.

While the applicator tampon is protected by the rigid applicator deviceand the applicator tampon need not as have as high a degree of columnstrength as a digital tampon, applicator tampons do require dimensionalstability (especially radial) to be acceptable for use. This dimensionalstability provides assurance, for example, that the tampon will notprematurely grow and split its packaging material or become wedged in atampon applicator.

Further, the intravaginal device can be collapsed for packaging andinsertion. For example, at least a portion of a major surface of thefluid transport element 12, such as the first surface 30, may be incontact with at least a portion of an outer surface of the fluid storageelement 14. This can be achieved by wrapping the fluid transportelement(s) around the fluid storage element 14 (as shown in FIG. 4 b).Alternatively, the fluid transport element(s) 12 may be folded orpleated (e.g., in an accordion-like manner) against the fluid storageelement 14. The thus-compacted device can then be packaged, (e.g.,within an applicator or alone in a wrapper). FIG. 20 shows a wrappedtampon within an applicator 68 (in phantom).

The specification and embodiments above are presented to aid in thecomplete and non-limiting understanding of the invention disclosedherein. Since many variations and embodiments of the invention can bemade without departing from its spirit and scope, the invention residesin the claims hereinafter appended.

1. Apparatus for producing an intravaginal device comprising: a. aforming tool comprising: i. a holding plate having a plurality of vacuumports formed in a face thereof; ii. a substantially circular aperturedisposed on the plate having a plurality of slots connected to andextending therefrom; b. a male tool comprising a plurality of formingblades, each blade having a guide edge, arranged radially about anaperture; c. At least one bonding element moveable toward the aperturein the forming tool; and d. at least one pushrod moveable through theapertures of each of the forming tool and the male tool; wherein theapertures of the forming tool and male tool are aligned along a machineaxis to permit the pushrod to move fluid storage element through eachaperture, the forming blades of the male tool are aligned with the slotsof the forming tool, and the guide edges of the forming blades arearranged and configured to accommodate a fluid storage element alignedwith the aperture of the male tool.
 2. Apparatus of claim 1 wherein eachforming blade has a pleating edge engageable with a sheet held on theface of the holding plate.
 3. Apparatus of claim 2 wherein the pleatingedge is adjacent the guide edge.
 4. Apparatus of claim 2 wherein thepleating edge is separated from the guide edge by at least oneintermediate portion of the forming blade.
 5. Apparatus of claim 1wherein the at least one bonding element is moveable in a plane parallelto the face of the holding plate.
 6. Apparatus of claim 5, wherein theat least one bonding element is moveable to extend into a space betweenadjacent forming blades when the forming tool and male tools are in anengaged position.
 7. Apparatus of claim 1 wherein the at least onebonding element is a thermobonding element.
 8. Apparatus of claim 1wherein the fluid storage element has a length, and the guide edge ofeach forming blade has a length that is not greater than the length ofthe fluid storage element.
 9. Apparatus of claim 1 wherein the fluidstorage element has a length, and the guide edge of each forming bladehas a length that is greater than the length of the fluid storageelement.